NATO Examines Federal Age 21 Bill, Heat-Not-Burn Product

LAKEVILLE, Minn. — Last month, there were two significant developments at the federal level related to tobacco and nicotine products. First, a Republican leader in Congress announced a legislative effort to raise the age to purchase tobacco products. Shortly thereafter, the U.S. Food and Drug Administration (FDA) announced that it had authorized the marketing of new tobacco products manufactured by Philip Morris International, New York, for its IQOS and HeatSticks tobacco products that allow adult consumers to simulate the smoking experience by heating rather than burning tobacco.

One day after announcing his reelection campaign, U.S. Senate Majority Leader Mitch McConnell (R-Ky.) announced that he would pursue federal legislation that would increase the legal age of purchase for tobacco products from 18 to 21 at the national level. Calling his proposal “a top priority,” McConnell indicated he was responding to the increase in vaping by teenagers.

McConnell indicated that he believes that many 18-year-old students still in high school who can legally purchase tobacco products and electronic cigarettes are sharing them with underage friends. He hopes his legislation takes a meaningful step toward stemming this process. If enacted into law, it is believed that this is the first time the government would enact such an age-restriction federally. While a person must be 21 to purchase alcohol across the country, those age limits were enacted not by the federal government but by states.

It is worth noting that while some states adopted the higher alcohol-purchase age voluntarily, others were pressured into raising the age because the federal government ultimately required states to raise the legal age to purchase alcohol for them to continue to receive road and highway funding.

Then, the FDA approved the premarket tobacco application (PMTA) filed by Philip Morris for its heat-not-burn IQOS product. This determination will now allow adult smokers and tobacco consumers access to Philip Morris’ IQOS product that heats a stick of tobacco without burning it. The product is designed to allow users to inhale aerosol with significantly reduced levels of chemicals than would otherwise be produced by burning tobacco. In approving the PMTA after its “rigorous science-based review,” the FDA determined that IQOS’ entry to the market “is appropriate for the protection of the public health.”

The IQOS product has already been marketed in several countries including Japan and more recently South Korea. In addition to the PMTA filed by Philip Morris with the FDA, the company also filed modified risk tobacco product (MRTP) applications for the products. Approval of the MRTP applications by the FDA would allow the manufacturer to make specific and limited health claims related to the product. The agency has yet to announce a decision related to the MRTP applications.